Straumann USA LLC recalls Custom Abutment AS Ti

Recalling company

Straumann USA LLC

Product

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

Reason

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 17, 2026

Reported

Apr 1, 2026

Distribution

Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada.

Status

Ongoing

Quantity

7 units

Lot / codes

Catalog Number/Art.: 010.5438; UDI-DI: 07630031773937; Order number (lot): 71315US_00729_01_b00, 91076US_03269_00_b00, 72509US_01048_00_b00, 72839US_00065_00_b00, 39133US_11508_02_b00, 4202CA_00558_00_b00, 72630CA_00109_00_b00;

Company location

Andover, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-1633-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1633-2026 in the FDA Enforcement Report. Also see FDA recall press releases.